DIA 2020 Global Annual Meeting

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A Risk-Based Approach to Implement Audit Trail Review and Inspection Readiness Plans in a Data Integrity Conscious World

Session Chair(s)

Paula Horowitz

Program Manager, QA, GCP Software Validation

AbbVie, United States

Given the current regulatory landscape, we will focus on what each organization should consider using a risk-based approach to be inspection ready, specifically regarding audit trail review and compliance with data integrity.

Learning Objective : Define GCP for data quality and data integrity specific to audit trail generation and review. Describe the current regulatory framework for organizational data governance, data integrity, audit trail review and inspection readiness within this framework.

DIA 2020 Global Annual Meeting

A Risk-Based Approach to Implement Audit Trail Review and Inspection Readiness Plans in a Data Integrity Conscious World

Session Chair(s)

Paula Horowitz

Learning Objective : Define GCP for data quality and data integrity specific to audit trail generation and review. Describe the current regulatory framework for organizational data governance, data integrity, audit trail review and inspection readiness within this framework.

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